Summary of Trisalus Life Sciences Conference Call Company Overview - **Company**: Trisalus Life Sciences (NasdaqGM: TLSI) - **Focus**: Improving outcomes for patients with solid tumors in the liver, pancreas, and other areas through innovative delivery technologies [2][3] Core Technology and Market Opportunity - **Technology**: A catheter-based system that modulates pressure and flow to enhance drug delivery directly into tumors, minimizing off-target effects [3][4] - **Market Size**: The company operates in a market opportunity of approximately $500 million, with less than 10% market share currently [3][4] - **Growth Potential**: Rapid growth anticipated due to the versatility of the technology for various embolization applications [4] Innovations in Treatment - **Thyroid Artery Embolization**: A new approach developed by Dr. Juan Camacho, aimed at treating multinodular goiter as a minimally invasive alternative to surgery [10][12] - **Patient Outcomes**: The technology has shown a 50% reduction in post-procedure readmissions due to fewer complications [8][9] Multinodular Goiter Insights - **Prevalence**: Approximately 12% of the adult population worldwide has multinodular goiter, with a significant number undergoing thyroidectomies annually [17][18] - **Surgical Risks**: Many surgeries are performed by general surgeons, leading to disparities in outcomes compared to specialized surgeons [18][19] - **Symptoms and Complications**: Patients often experience significant morbidity, including hyperthyroidism and compressive symptoms [21][23] Treatment Paradigms - **Minimally Invasive Options**: Options include radioactive iodine, percutaneous ethanol injection, ablation, and thyroid artery embolization [25][31] - **Volume Considerations**: Larger nodules (>20 mL) are more effectively treated with thyroid artery embolization due to high recurrence rates with other methods [27][28] Clinical Evidence and Results - **Efficacy of Embolization**: Studies indicate that thyroid artery embolization can reduce thyroid volume by approximately 50% and improve hormone levels without causing hypothyroidism [36][37] - **Quality of Life Improvements**: Significant improvements in quality of life reported post-procedure, with a high euthyroid conversion rate in patients with hyperthyroidism [38][39] Future Directions - **Research and Guidelines**: Ongoing efforts to build robust clinical data and establish guidelines for patient selection and treatment protocols [54][56] - **Awareness and Training**: Emphasis on increasing awareness of the procedure among patients and healthcare providers, and ensuring proper training for practitioners [64][65] Conclusion - **Emerging Treatment**: Pressure-enabled thyroid artery embolization presents a promising alternative for patients with large goiters, particularly when surgery poses high risks [52][53] - **Multidisciplinary Approach**: Collaboration among various specialties is crucial for optimizing patient care and integrating this technology into standard practice [64][65]

Company Overview - TriSalus Life Sciences is a mission-driven company focused on enhancing drug delivery to pancreatic, liver, and solid tumors [3] - The company is developing nelitolimod, an immunotherapeutic aimed at reversing immunosuppression in tumors, with the goal of improving patient outcomes for those suffering from serious cancers [3] Event Highlights - The inaugural webinar features discussions on uterine fibroids embolization, presented by distinguished physicians Dr. Nicole Lamparello and Dr. Francis Kang, highlighting it as a preferable alternative to surgery for patients with uterine fibroids [2] - The event aims to illustrate the value of TriSalus's technology in addressing significant medical challenges [2]

TriSalus Life Sciences Conference Call Summary Company Overview - **Company**: TriSalus Life Sciences (NasdaqGM: TLSI) - **Focus**: Improving drug delivery to pancreatic, liver, and solid tumors, with a specific emphasis on a drug called nelitolimod, an immunotherapeutic aimed at reversing immunosuppression in tumors [2][3] Industry Insights - **Uterine Fibroids**: The call highlighted uterine fibroid embolization as a preferable alternative to surgery for patients suffering from uterine fibroids [2][10] - **Interventional Radiology (IR)**: The field has evolved significantly, with IR now recognized as a primary specialty in medicine, performing minimally invasive procedures using image guidance [12] Key Technology and Innovations - **Pressure-Enabled Drug Delivery**: TriSalus's technology modulates pressure and flow to enhance therapeutic delivery to tumors while minimizing exposure to normal tissues [3][5] - **TriNav Infusion System**: A proprietary system designed to improve the delivery of therapeutic agents, particularly in uterine artery embolization [8][10] - **Smart Valve Technology**: This technology allows for better perfusion of drugs into tumors by opening collapsed vessels and enhancing blood flow [5][6] Clinical Evidence and Outcomes - **Uterine Artery Embolization (UAE)**: - UAE is effective for treating uterine fibroids and adenomyosis, providing significant symptomatic relief and a minimally invasive option compared to traditional surgical methods [16][19] - Clinical data showed that UAE is as effective as surgical alternatives, with a slightly higher re-intervention rate [19] - A study indicated a 100% technical and clinical success rate in patients using the TriNav catheter, with significant reductions in heavy menstrual bleeding and pain scores [26][27] Market Dynamics - **Awareness and Education**: There is a lack of awareness among patients and healthcare providers regarding UAE, with many women unaware of this treatment option [17][50] - **Referral Pathways**: Improved collaboration between interventional radiologists and gynecologists is essential to enhance patient access to UAE [50][53] - **Cost-Effectiveness**: The TriNav technology has been shown to be cost-saving due to reduced complications and improved therapeutic delivery, which is appealing to payers [65] Future Directions - **Patient Education Initiatives**: TriSalus plans to enhance patient education through social media and direct outreach to improve awareness of UAE [55][56] - **Research and Data Publication**: Ongoing efforts to publish clinical data supporting the efficacy of TriSalus's technologies will help influence treatment decisions among patients and providers [58] Conclusion TriSalus Life Sciences is positioned to make significant advancements in the treatment of uterine fibroids and solid tumors through innovative drug delivery technologies and a focus on patient education and awareness. The company aims to bridge the gap between interventional radiology and gynecology to improve patient outcomes and expand the adoption of minimally invasive procedures.

Financial Data and Key Metrics Changes - TriSalus achieved $29.4 million in net sales for 2024, reflecting a 59.4% growth over 2023, marking it as one of the fastest-growing med tech companies [12][27] - Revenue for Q4 2024 reached $8.3 million, representing a 44% increase compared to Q4 2023 and a 12% sequential increase from Q3 2024 [27] - Operating losses for Q4 2024 totaled $7.6 million, compared to losses of $14.2 million in Q4 2023, with year-to-date losses in 2024 amounting to $36.2 million compared to $54.5 million in 2023 [32] Business Line Data and Key Metrics Changes - The number of unique ordering accounts increased by 43% year-over-year from 199 to 284, with account utilization improving as average units sold per ordering account rose 10% from 12.3 to 13.5 units [13][14] - The launch of the TriNav LD infusion system and TriGuide guiding catheter expanded the PEDD portfolio, optimizing therapeutic delivery and improving procedural efficiency [18] Market Data and Key Metrics Changes - TriSalus captured 9% of the liver, TACE, and TARE procedures market in 2024, with 103 new hospital accounts opened year-to-date [28] - The PROTECT registry study is evaluating TriNav for non-malignant thyroid goiters and nodules, representing a market of approximately 50,000 annual procedures and a $400 million incremental opportunity [15] Company Strategy and Development Direction - The company prioritized its pressure-enabled drug delivery technology, aiming for EBITDA positivity by mid-2025 and cash flow positivity by year-end 2025 [10][22] - Strategic partnerships are being sought to advance the nelitolimod program in uveal melanoma liver metastases, with a focus on expanding reimbursement for radioembolization mapping [19][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% revenue growth in 2025, alongside positive full-year EBITDA and cash flow in the second half of 2025 [22][29] - The company aims to deepen penetration in the complex liver embolization market and enhance health economic and outcome research data [21][23] Other Important Information - TriSalus secured up to $50 million in debt financing from OrbiMed to support growth initiatives, with $35 million accessed to date [20] - The company filed a Form 12b-25 notification of late filing with the SEC due to errors identified in stock-based compensation and clinical trial-related R&D expenses [25][26] Q&A Session Summary Question: Where is the uptake for the launch of TriNav large vessels? - Management noted that TriNav is primarily being used in TARE more than TACE, particularly for larger vessel applications [36][38] Question: Can you provide insight on current mapping with TARE? - Management confirmed that the new CMS code allows for mapping and treatment in Medicare patients, which opens up about 25% of the market [41][46] Question: What should be expected in the PERIO-03 data? - Management clarified that the Phase I study is not to be compared to systemic chemotherapy, focusing instead on the technology's safety and efficacy [49][50] Question: Can you provide more color on account openings? - Management indicated a deliberate strategy to focus on driving utilization in existing accounts rather than aggressively opening new ones [63][65] Question: What is the attachment rate of mapping cases today in commercial? - Management believes the attachment rate is close to one-to-one on the commercial side, as mapping with the same technology yields better outcomes [80][81] Question: What is the status of the 10-K filing delay? - Management is working through the audit process and is hopeful that the numbers will not change significantly [90][92]

Financial Data and Key Metrics Changes - TriSalus achieved $29.4 million in net sales for 2024, reflecting a 59.4% growth over 2023, marking it as one of the fastest-growing med tech companies [12][27] - Revenue for Q4 2024 reached $8.3 million, representing a 44% increase compared to Q4 2023 and a 12% sequential increase from Q3 2024 [27] - Operating losses for Q4 2024 totaled $7.6 million, a decrease from $14.2 million in Q4 2023, with year-to-date losses amounting to $36.2 million compared to $54.5 million in 2023 [32] Business Line Data and Key Metrics Changes - The company reported a 44% growth in Q4 and 59% operational growth for the full year, driven by the success of the TriNav device [11][27] - The number of unique ordering accounts increased by 43% year-over-year, from 199 to 284, with account utilization improving by 10% [13][14] - The launch of new products, including the TriNav LD infusion system and TriGuide guiding catheter, expanded the PEDD portfolio [18] Market Data and Key Metrics Changes - TriSalus captured 9% of the liver, TACE, and TARE procedures market in 2024, with 103 new hospital accounts opened [28] - The company reported a robust gross margin profile of 85% in Q4 2024, down from 90% in Q4 2023, but maintained an overall gross margin of 86% for the full year [29] Company Strategy and Development Direction - The company is focusing on expanding its PEDD technology into new clinical applications while reducing R&D expenses to achieve EBITDA positivity by mid-2025 [10][11] - Strategic partnerships are being sought to advance the nelitolimod program, particularly in uveal melanoma liver metastases [19] - The company aims to deepen penetration in the complex liver embolization market and enhance health economic and outcome research data [21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving over 50% revenue growth in 2025, alongside positive EBITDA and cash flow in the second half of the year [22][23] - The company acknowledged the challenges posed by the economic environment but emphasized strong commercial momentum and a clear path to growth [10][11] Other Important Information - TriSalus secured up to $50 million in debt financing from OrbiMed to support growth initiatives, with $35 million accessed to date [20] - The company filed a Form 12b-25 notification of late filing with the SEC due to errors in stock-based compensation and R&D expense timing [25][26] Q&A Session Summary Question: Uptake of TriNav large vessels in TACE and TARE procedures - Management noted increased use in TARE more than TACE, particularly for larger vessel applications [37][39] Question: Current mapping with TARE and new CMS code impact - The new CMS code allows for mapping and treatment in Medicare patients, opening up about 25% of the market previously not accessible [46][72] Question: Insights on PERIO-03 data - The Phase I study is focused on safety and technology success, with results expected mid-2025 [50][52] Question: Guidance for Q1 and year cadence - Management indicated that while growth may not be uniform, they remain optimistic about achieving the 50% growth target for the year [61][98] Question: Account openings and utilization strategy - The company is shifting focus from opening new accounts to driving utilization in existing accounts, with a balanced approach moving forward [65][66] Question: Mapping attachment rate in commercial cases - Management believes the mapping attachment rate is close to one-to-one in commercial cases, emphasizing better outcomes with the same technology [81][82] Question: Next steps for pancreatic trials - A Phase II or III trial is likely, with potential for partnership, pending data from ongoing studies [88] Question: Status of 10-K filing delay - The audit is ongoing, and management is committed to transparency regarding any changes in financial results [91][92]